Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K901626 |
Device Name |
H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED |
Applicant |
MED-TEK CORP. |
6535 E. 82ND ST. |
SUITE 215 |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
KENNETH EPLING |
Correspondent |
MED-TEK CORP. |
6535 E. 82ND ST. |
SUITE 215 |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
KENNETH EPLING |
Regulation Number | 888.3330
|
Classification Product Code |
|
Date Received | 04/09/1990 |
Decision Date | 08/14/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|